Machine Vision Based MDS-UPDRS III Machine Rating

Machine Learning Clinical Trial

Official title:

Machine Vision Based Machine Rating of MDS-UPDRS III

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906719
• Other study ID #: u3
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: March 2023
• Source: Ruijin Hospital
• Contact: Lun Liu, MD,PhD
• Phone: 021-86-64370045
• Email: jly0520[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Movement Disorders Society (MDS) Unified Parkinson's Disease Rating Scale (UPDRS) Part III (MDS-UPDRS III) is the primary assessment method for motor symptoms in Parkinson's disease patients. Currently, movement disorder specialists conduct semi-quantitative scoring, which entails limitations such as subjectivity, weak sensitivity, and a limited number of professional physicians. This study, based on machine vision, establishes gold standard labels according to expert scoring. By using machine learning, we develop a machine rating model and compare the model's performance with gold standard rating and general clinical rating to investigate the accuracy of machine vision-based MDS-UPDRS III machine rating.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 871
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Meeting the diagnostic criteria for Parkinsonism established by the International Movement Disorder Society: having bradykinesia, and meeting at least one of the two criteria for resting tremor or muscle rigidity
• 20 to 80 years old
• Good compliance, voluntarily joining the study, and able to sign an informed consent form or have it signed by a legal representative

Exclusion Criteria:

• Significant cognitive impairment (MMSE = 23)
• Unable to sign written informed consent or unable to complete the trial due to other reasons
• Other situations in which the researcher deems the participant unsuitable for this study
• Participation in other clinical trials

Related Conditions & MeSH terms

• Machine Learning
• Parkinsonian Disorders

Intervention

Other:
• video recording
Patients' performance of MDS-UPDRS III will be recorded.

Locations

Country	Name	City	State
China	Beijing Hospital, Neurology Department	Beijing	Beijing
China	Center for Movement Disorders, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Department of Neurology, West China Hospital, Sichuan University	Chengdu	Sichuan
China	Department of Neurology, Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Department of Neurology, Guangdong Neuroscience Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences	Guangzhou	Guangdong
China	Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Department of Neurology and Clinical Research Center of Neurological Disease, The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (8)

Lead Sponsor	Collaborator
Ruijin Hospital	Beijing Hospital, Beijing Tiantan Hospital, Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, Second Affiliated Hospital of Soochow University, West China Hospital, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACC0 of machine rating vs gold standard rating	The accuracy rate when machine rating equals gold standard rating.	1 day
Primary	ACC1 of machine rating vs gold standard rating	The accuracy rate when machine rating equals the range of gold standard rating plus or minus one.	1 day
Primary	Weighted kappa of machine rating vs gold standard rating	The weighted kappa when machine rating equals gold standard rating.	1 day
Primary	Lin's CCC of machine rating vs gold standard rating	The Lin's Concordance Correlation Coefficient when machine rating equals gold standard rating.	1 day
Secondary	Accuracy rate of machine rating vs general clinical rating	Comparing the absolute residuals between machine rating and the gold standard rating with the absolute residuals between general clinical raitng and the gold standard rating.	1 day
Secondary	Accuracy rate of machine facilitated rating vs general clinical rating	Comparing the absolute residuals between machine facilitated rating and the gold standard rating with the absolute residuals between general clinical raitng and the gold standard rating.	1 day